Institutional Review Boards: The Basics

What do they do?

The responsibilities of Institutional Review Boards (IRBs) fall into two main categories:
initial review and continuing review of research involving human subjects.

Initial Review: IRBs review and approve a research plan before the research is carried out. This
review encompasses the research protocol, the informed consent document to be signed
by subjects, any advertisements to be used in recruiting subjects, and other relevant
documents. In carrying out this review, the board seeks to ensure any risks subjects
may incur are warranted in relation to the anticipated benefits, that informed consent
documents clearly convey the risks and the true nature of research, advertisements
are not misleading, and the selection of subjects is equitable and justified. IRBs
focus much attention on the informed consent document as it is the vehicle for providing
information to potential research subjects.

Continuing Review: The continuing review process is multifaceted and includes required reviews "at an
interval appropriate to the degree of risk but not less than once per year." In addition
to this continuing review, study amendments and reports of unexpected adverse experiences
by subjects are received periodically and reviewed to ensure that the risk-benefit
ratio of the research has not changed and remains acceptable.

Why were they established?

As public awareness and concern about the treatment of human subjects in research
increased, the need for additional review mechanisms was evident. These concerns
grew from stories of the abuse of subjects during the World War II trials at Nuremburg,
the promotional distribution of thalidomide resulting in numerous children born with
birth defects, the administration of cancer cells to chronically ill and senile patients
at a hospital in New York, and others. A 1966 article by Henry Beecher brought prominent
attention to human research abuses in medical schools and hospitals citing 22 cases
involving highly questionable ethics. The formal requirements for the establishment
of IRBs were outlined in regulations stemming from the National Research Act of 1974
and in FDA regulations issued in 1981.

Where are they located?

An estimated 3,000-5,000 IRBs can be found across the country. They are most commonly
associated with hospitals and academic centers. Boards also exist in managed-care
organizations, government agencies (such as the National Institutes of Health, the
Centers for Disease Control, and State governments), or as for-profit entities that
are independent of the institutions in which the research takes place.

How are they organized?

Federal regulations require that boards have at least five members with varying backgrounds.
At least one member must have primarily scientific interests, one must have primarily
nonscientific interests, and one must be otherwise unaffiliated with the institution
in which the IRB resides. A quorum, with at least one member whose interests are
primarily nonscientific present, is needed for voting.